OPINION:
Mistakes aplenty have occurred in the unprecedented battle against COVID-19, but governing in the modern era apparently means never having to explain. As the war against the pandemic dwindles toward the close of its third year, Americans are still pondering the wisdom of shortcuts taken by Washington’s apothecaries in creating their novel vaccines — and whether apologies are appropriate.
With pharmaceutical firms, Pfizer and Moderna receiving approval for their new boosters, the issue of full disclosure as the basis for informed consent returned to the front burner. “We are launching a new vaccine – our first in almost two years – with a new approach. For most Americans, that means one COVID-19 shot, once a year, each fall,” President Joe Biden said Tuesday in a statement.
The apothecary-in-chief did not mention the fresh vaxxes, reformulated to combat the original virus as well as the more recent BA.4 and BA.5 Omicron variants, have not been put through human trials. Rather, the formulas have been tested on intrepid mice.
This nugget of information may be disturbing, but mostly only to individuals who somehow overlooked the fact that customarily performed human trials of the original messenger RNA COVID-19 vaccines were cut short and in 2021, the drugs were granted “emergency use authorization.” Manufacturers argued that injecting vulnerable patients with a placebo rather than their experimental virus-fighting drug could result in their deaths, violating the paramount medical principle: “First, do no harm.”
To be sure, speed versus safety in drug development is a gut-wrenching ethical balancing act when people are suffering. The decision to err on the side of haste, though, has carried a cost: The U.S. system for collecting reports of adverse reactions to vaccines has collected more than 900,000 reports related to the COVID shots. The system logs all reports of adverse reactions after a vaccine is given. They are unverified and don’t necessarily relate to the vaccine.
Still, the numbers show COVID shots account for 56% of all ill reactions reported for nearly 100 U.S.-licensed vaccines of all sorts since 1990, according to the U.S. Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System. The most adverse event of all, of course, is death, and the system reports more than 17,000 deaths that occurred after a vaccine was administered.
Reasonable Americans may question the wisdom of presenting their arms for new versions of drugs that have proved life-saving for most, but life-threatening for too many. Rep. Thomas Massie, Kentucky Republican, summarized the unwelcome choice in a recent tweet: “Some are saying there are no human trials for the newest COVID-19 boosters being administered this fall. I beg to differ. If you take this booster, you are the human trial.” It’s a jarring – but not untrue — way of putting it.
Americans one and all are relieved that the pandemic is on the ebb. At the same time, they have learned not to put all their trust in the efficacy of medical remedies that conflate the testing of mice and men. After all, despite 84% of the U.S. population having received at least one vaccine dose, more than 70% have nevertheless caught COVID-19, according to the CDC.
Since garnering praise for success is more gratifying, Americans aren’t likely to receive apologies from Washington’s apothecaries for shortcuts that result in shortcomings among their experimental vaccines.
Update: This editorial has been updated to better describe the U.S. system for reporting adverse reactions to vaccines.
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